The Food and Drug Administration (FDA) recently announced a plan for “policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.” FDA Commissioner Scott Gottlieb reflected on the 25th anniversary of the Dietary Supplement Health and Education Act, and stated his commitment to ensuring FDA achieves the right balance between consumer access to lawful supplements, while upholding the agency’s public health obligation to protect consumers from unsafe and unlawful products, and holding unlawful actors accountable. The announcement sets lofty goals and teasers for details that are forthcoming. FDA also articulates several priorities for modernizing and reforming its oversight of dietary supplements, as discussed further below. As a part of these efforts, the agency issued over a dozen Warning Letters to companies marketing products as dietary supplements but that were labeled with unapproved disease claims, such as claims about the prevention of Alzheimer’s disease.

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The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued a Draft Guideline detailing the Agency’s expectations of companies that identify foreign material in their meat and poultry products and more generally providing recommendations for how establishments should craft their complaint handling policies. FSIS states that it developed the document in response to an increase in the number of recalls of meat and poultry products adulterated with foreign materials, many of which occurred after the recalling establishments had received multiple customer complaints. Though the document is intended to address foreign material customer complaints specifically, FSIS notes that establishments can apply the information in the document to other customer complaints of adulterated or misbranded products in commerce. The Draft Guideline marks a significant expansion in FSIS’s formal guidance about complaint handling programs and signals continued Agency focus on foreign material issues.

According to FSIS, the Draft Guideline reflects the Agency’s current thinking and “should be considered useable as of the issuance date.” The document technically “is not regulatory” (i.e., is not binding), and establishments may choose to adopt different procedures than those outlined in the Draft Guideline, although in practice FSIS will typically expect the establishment to justify alternative practices. Comments are due by May 10, 2019 and should be submitted to Docket Number FSIS-2018-0034.

This blog post first summarizes FSIS’s statements in the Draft Guideline on foreign material control generally, followed by the Agency’s guidance on complaint handling.

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Hogan Lovells will offer a free seminar on new U.S. food manufacturing, labeling, and inspection requirements that apply to any Mexican company exporting food to the U.S. These requirements cover both finished goods and ingredients.

Hogan Lovells U.S. partners Maile Hermida and Elizabeth Fawell will be visiting from Washington, D.C. to discuss these latest U.S. food law developments and how they affect all foreign companies that sell food to the U.S.

Who should attend?
Regulatory, quality control, and legal personnel from Mexican companies that export or intend to export food to the U.S.

Why attend?
Mexican companies that export food to the U.S. are required to follow U.S. requirements for manufacturing and labeling. They also are subject to inspection by the U.S. Food and Drug Administration.  Further, new U.S. requirements for U.S. food importers mean that Mexican food exporters will be subject to greater scrutiny by and questions from their customers. Failure to meet new U.S. food requirements can result in food being held up at the U.S. border and refused admission.

Continue Reading New laws affecting Mexican food exporters – What you need to know to sell food in the U.S.

The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) announced today a formal-agreement coordinating joint jurisdiction over the production of products derived from cell lines of livestock and poultry. This agreement marks the next significant step in establishing the regulatory framework for these products and delineates the general roles that FSIS and FDA will play in regulating the developing of cell lines, culturing cells, harvesting cells, processing products from those cell cultures, labeling, and post-market enforcement. It builds on a November 2018 joint statement by USDA Secretary Perdue and FDA Commissioner Gottlieb last Fall, in which they announced that the agencies would establish a coordinated framework for regulating these products working within their existing statutory authorities. Although today’s formal agreement establishes a general regulatory framework, additional work remains, as both agencies will have to review and possibly update regulations, develop more specific regulatory guidance for these products, and resolve a number of important questions.

In general, the formal agreement adopts a “pre-harvest” and “post-harvest” approach, with FDA asserting oversight “through the time of harvest” and FSIS assuming jurisdiction over harvested cells that are intended for use in meat or poultry products. The agreement leaves jurisdiction at the point of “harvest” unresolved, with the agreement apparently contemplating both agencies having a role. The agreement calls for information sharing and coordination between FDA and FSIS, and the agencies have committed to a collaborative process for fleshing out the regulatory process moving forward.

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If you make a living producing and selling alcohol beverages, congratulations! You are beloved by many. As someone who manufacturers spirits, wine, beer, or other alcohol beverages, you not only address the high demand for your libations, but also the complex and often confusing regulations that affect your business. Now, however, you have the opportunity to participate in a major regulatory revision concerning your products.

As you may know, the Alcohol and Tobacco Tax and Trade Bureau (TTB) is the primary federal agency that regulates alcohol and has specific oversight of the labeling and advertising of these beverages. On Nov. 26, TTB proposed modernizing the regulations that govern the labeling and advertising of alcohol beverages.

The primary goal of this proposal is to make current regulations simpler and clearer for business owners so that compliance will be easier for industry members.

Click here to read some of the top takeaways from the proposed rule.


This op-ed was originally published on Food Dive. Food Dive is a daily news publication that provides busy food manufacturing professionals with a bird’s-eye-view of the Food industry in 60 seconds. Sign up here

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently issued a statement affirming that Produce Safety Rule inspections will begin this spring. Last year FDA chose to delay routine inspections to allow more time for farmers and state regulators to receive training on the rule. Routine inspections for large farms (i.e., farms with more than an average $500,000 in produce sales during the previous 3-year period) were delayed until spring 2019, and routine inspections for small farms, other than sprouts operations, were delayed until spring 2020. In his statement, Commissioner Gottlieb confirmed that routine inspections for large domestic and foreign farms will commence this spring, as planned.

FDA also has established a Produce Inspections webpage to serve as a central location for farms and state partners to find resources related to inspections. The webpage includes a new Fact Sheet with information on what farms should expect of their first inspection. It also includes new documents to be used during Produce Safety inspections, including the recently developed inspectional observation form and a procedure for dispute mitigation and resolution.

This blog briefly summarizes the fact sheet and new inspection documents, including FDA Form 4056 and Produce Safety Dispute Mitigation and Resolution Procedures. Click here to read more.

The U.S. Food and Drug Administration (FDA) has issued final Guidance regarding Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. The document makes limited changes to the Draft Guidance that was issued in January 2018. The Guidance outlines circumstances when a company should issue a public warning about a voluntary recall, describes the general timeframe for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient. The document’s recommendations apply to all voluntary recalls, including both firm-initiated and FDA-requested recalls, and covers foods and dietary supplements (as well as all other FDA-regulated products).

This blog provides background for FDA’s development of the Guidance, as well as a high-level summary of the Guidance’s recommendations. Click here to read more.

What are the 3 letters that should strike fear into the heart of every food executive?  No, the 3 letters are not F-D-A.  Although the Food and Drug Administration is quite powerful, the agency can only wield that power against a particular food company ­­­­when it has the evidence to do so.

The 3 letters we are referring to are W-G-S – which stands for Whole Genome Sequencing – because this new scientific tool can give FDA that evidence – indeed, compelling evidence that a food needs to be recalled and, potentially, that a food facility needs to be shut down.  In this way, WGS is truly revolutionizing food safety.

Here is what we mean.  Even though there are hundreds of types of Salmonella – the most prevalent pathogen – each individual Salmonella strain found has its own unique gene sequence.  Think of it like a super fingerprint.

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Please join us at 2 p.m. on Tuesday, February 26 for a webinar on the regulatory landscape for hemp-derived products, including cannabidiol, or CBD.

Martin J. Hahn and Samantha Dietle will provide an overview of the impact that changes to the Farm Bill will have on the FDA regulation of hemp and hemp-derived ingredients, as well as the Food and Drug Administration’s authority to regulate the use of hemp-derived ingredients in FDA-regulated foods, dietary supplements, and cosmetics.

Delia A. Deschaine will explore the Drug Enforcement Agency’s historical regulation of cannabis-derivatives under the Controlled Substances Act and the unique issues presented by the development of cannabis-derivatives as approved new drugs under the DEA’s and FDA’s authority.

Please click here to register for this complimentary webinar. 

As previously reported, the Food and Drug Administration (FDA) and the U.S Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) are operating under significantly reduced functions since funding for the agency lapsed on December 22, 2018. Recently, there have been a number of media reports with updated information from FDA Commissioner Gottlieb regarding the scope of FDA food facility inspections during the government shutdown, which is summarized in this memorandum. We will continue to monitor major developments related to the scope of FDA’s food safety activities during the government shutdown; food companies may also wish to follow Commissioner Gottlieb’s Twitter account for the most recent developments on this issue. In a related update, we understand that FSIS is now in the process of reviewing label submissions in a limited capacity.

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